MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS UVAR XTS SYSTEM

Model Number 6660

Device Problem Lens washers, failure of (1367)

Patient Problem Twitching (2172)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

Customer called to report a blood leak that occurred during treatment.Name and function of complainant: same as reporter.Customer called to report blood leak during cycle 1.Customer stated there was a blood leak alarm and when the centrifuge chamber door was opened, there was blood leaking from the neck of the centrifuge bowl.Customer stopped the procedure without returning any blood/products to the patient.Css asked customer if there were any alarms prior to the blood leak alarm.Customer states there were multiple empty a/c alarms.Css asked if there was any clotting or occlusions observed in the kit when it was removed.Customer stated there was no clotting or any occlusions in the kit.Css asked if patient was stable, and customer stated patient was stable and asymptomatic.They were able to start another procedure on this patient.No kit was returned for investigation.

Manufacturer Narrative

Batch record review of lot a908 was conducted.There were no non-conformities related to this type of failure for this lot.Lot met release requirements.Trends have been reviewed on a lot by lot basis for this complaint category and no trend has been detected for this specific lot.The assessment is based on information available at the time of the investigation.No product was returned by customer for investigation; therefore, no root cause could be determined at this time.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action will be taken.

• Brand Name: THERAKOS UVAR XTS SYSTEM
• Type of Device: XTS
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east ste 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3824068
• MDR Text Key: 4400790
• Report Number: 2523595-2014-00048
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: 6660
• Device Lot Number: A908 KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 186